8chan/8kun QResearch Posts (3)
#22910855 at 2025-04-14 18:05:58 (UTC+1)
Q Research General #27968: Bukele Meets The Cabinet Edition
Trump Administration Fast-Tracks Controversial Self-Amplifying mRNA Vaccine for H5N1 Bird Flu
The Trump administration has granted Fast Track designation to a groundbreaking - and controversial - self-amplifying mRNA (sa-mRNA) vaccine candidate targeting the H5N1 avian influenza virus.
The vaccine, ARCT-2304, developed by Arcturus Therapeutics, is now in Phase 1 trials and has been positioned by federal health authorities as a front-line defense against a potential bird flu pandemic.
The designation, announced April 10, was awarded by the U.S. Food and Drug Administration (FDA) in partnership with the Department of Health and Human Services and its Biomedical Advanced Research and Development Authority (BARDA).
The Fast Track designation from the FDA expedites the review of drugs intended for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
This designation aims to get new treatments to patients faster by encouraging more frequent communication between the FDA and the drug developer and allowing for a rolling review of the application.
Unlike traditional vaccines, the ARCT-2304 candidate uses a self-replicating mRNA platform, meaning the genetic material continues reproducing inside the recipient's cells to boost production of flu-fighting proteins. Arcturus claims this results in a stronger immune response with smaller doses.
"We are pleased to receive Fast Track Designation from the FDA for ARCT-2304," said Joseph Payne, President and CEO of Arcturus Therapeutics.
"We remain steadfast in our commitment to the U.S. government to develop safe and effective STARR® next-generation mRNA vaccines to protect U.S. citizens from future pandemic threats. This designation from the FDA is an important step forward in our mission to provide protective solutions for global health crises."
This experimental technology, dubbed STARR® and powered by Arcturus' proprietary LUNAR® delivery system, allows the vaccine to be freeze-dried and stored in refrigerators, avoiding the ultra-cold storage problems that plagued early COVID-19 rollouts.
Federal taxpayers are footing the bill - again. ARCT-2304 is being developed under a BARDA contract (No. 75A50122C0007), highlighting yet another example of public-private partnerships where the pharmaceutical industry reaps the profits and the people carry the risk.
BARDA, the same agency involved in Operation Warp Speed under the previous Trump term, has been given sweeping authority to fund and fast-track pandemic-related vaccines and therapeutics.
During the COVID-19 pandemic, many people reported side effects from mRNA COVID-19 vaccines, such as those from Pfizer-BioNTech and Moderna, leading to widespread complaints.
The mRNA vaccines work by instructing cells to produce a piece of the SARS-CoV-2 virus's spike protein, triggering an immune response. Approved under emergency use authorizations initially, these vaccines have been administered to billions globally, with full approvals following for certain age groups.
Concerns about side effects have been voiced, especially given the rapid rollout and the unprecedented scale of vaccination.
https://www.thegatewaypundit.com/2025/04/trump-administration-fast-tracks-controversial-self-amplifying-mrna/
#22910041 at 2025-04-14 14:16:51 (UTC+1)
Q Research General #27966: He is all, he thinks about: A is for Asshole Edition
>>22910025
>Trump FDA has granted fast track designation for a "self-amplifying mRNA vaccine"
"Fast tracked." Sure. Just like Moderna and DARPA and GATES, who HAD BEEN in development DECADES prior?
Spoopy name. Arcturus? Like Arcturians? They fucking ruin everything.
SAN DIEGO - Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT), a biotechnology firm specializing in mRNA medicines with a market capitalization of $266 million, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its self-amplifying mRNA vaccine candidate, ARCT-2304. The vaccine is aimed at providing immunity against the H5N1 subtype of influenza A, a virus with potential pandemic implications. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The Fast Track Designation is intended to facilitate the development and expedite the review of drugs and vaccines that treat serious conditions and fill an unmet medical need. Benefits of this designation include more frequent meetings with the FDA, potential for priority review, and the possibility of submitting sections of a New Drug Application on a rolling basis. While the company's stock has faced challenges, declining over 69% in the past year, InvestingPro analysis suggests the stock may be undervalued at current levels.
The Phase 1 clinical study for ARCT-2304 began in November 2024, testing its safety and efficacy. With a current ratio of 4.67, the company appears well-positioned to fund its clinical development programs. Joseph Payne, President and CEO of Arcturus, expressed the company's commitment to developing mRNA vaccines to protect against pandemic threats and regarded the FDA's recognition as a significant milestone in their mission.
ARCT-2304 utilizes Arcturus's proprietary LUNAR® delivery technology and STARR® mRNA technology. The vaccine is designed to replicate mRNA within host cells to produce antigens at lower doses than traditional mRNA vaccines. This technology also aims to facilitate quicker vaccine availability compared to conventional egg- and cell-based methods. Moreover, ARCT-2304's stability in refrigerator temperatures could improve distribution logistics.
https://www.investing.com/news/company-news/arcturus-vaccine-gets-fda-fast-track-for-h5n1-influenza-93CH-3979080
#19981326 at 2023-11-26 21:00:51 (UTC+1)
Q Research General #24529: Deep State Big Mad Edition
>>19981266
>>19981266
https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-third-quarter-2023-financial
New
We had considerable progress this quarter expanding our next generation STARR® vaccine platform," said Joseph Payne, President & CEO of Arcturus Therapeutics. "Our monovalent ARCT-154 COVID vaccine remains on track for approval in December and we reached our target enrollment for the bivalent COVID vaccine Phase 3 study, with PMDA-approval anticipated Q3 2024."